Kornimate/medical-research-clean huggingface dataset:
assessment of the fungal infection incidence across canada for high risk participants with hematological disease (p07501)

Conditions: Mycoses; Leukemia

Summary: this will be a retrospective study that includes retrospective chart reviews at major institutions across canada. the intent of the study is to generate both regional and national incidence data for non-candida invasive fungal infections (ifi) in high risk participants. the study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.


Eligibility criteria:
inclusion criteria: * to be eligible for study inclusion, the participant must have: * a hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant exclusion criteria: * the participant is not eligible for study inclusion if: * their ifi is not related to hematological malignancies.

Keywords: hematological malignancy fungal infection leukemia
effectiveness of mindfulness-based stress reduction program

Conditions: Stress

Summary: having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. in addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological well-being. in the long term, high stress levels can seriously compromise parents' mental health and reduce their overall quality of life. therefore, the development of effective stress management strategies and psychological support mechanisms for parents is critical not only for individual well-being but also for the health of family relationships. mindfulness practices, in this context, emerge as powerful tools with the potential to increase parents' ability to cope with stress and improve emotional well-being. therefore, this study aims to determine the effect of the mindfulness stress reduction program applied to parents of physically disabled children on stress and quality of life.


Eligibility criteria:
inclusion criteria: * being able to read and write * having a child diagnosed with a physical disability exclusion criteria: * having more than one physically disabled child

Keywords: mindfulness stress reduction program physically disabled parent quality of life stress
nasal appliance for the treatment of snoring in adult subjects - a pilot study

Conditions: Snoring

Summary: this is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (osa) and no need for cpap treatment: with standard diagnosis of sleep study or with minor sleep disorder (ahi of less than 15 events per hour). patients with no osa over the last year will sign an informed consent after receiving explanations from authorized physician (professor asher tal). the patient will than undergo a sleep study using a mobile device pat (peripheral arterial tomography, itamar medical, israel) ,an approved device in israel, usa and many other european countries,, approved for use by the usa fda). this sleep study is needed in order to rule out osa, namely ahi of more than 15 events per hour of sleep. the study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with pat device, with snoring recording and without the "forrest" epic device. in the second night the sleep study will be with pat device, with snoring recording and with the "forrest" epic device. the order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. the research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. the sleep studies will take place in a sleep laboratory (millennium sleep labs ltd, beer sheva) or as an ambulatory study, at home. recordings over the nights with or without the "forrest" epic device will be carried out at the patient's home, after verification that each patient sleeps alone in his/her room. the recording and data processing of snoring will be performed through the application "snorlab" on iphone 6 mobile device. ambulatory sleep studies with pat device will be carried out during two nights (with and without the forrest device) with most patients. during the examination, respiratory index will be tested such as: obstructive respiratory events during sleep, oxygen saturation in blood at rest (measured non-invasively) during sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of oxygen saturation in blood.


Eligibility criteria:
inclusion criteria: * the patient age range : 20-70 years old. * the patient / legal guardian able and willing to sign conscious written agreement. * the patient / legal guardian able and willing to comply with the study protocol. * the patient is suffering from snoring. * the patient underwent a sleep study over the last year. exclusion criteria: * the patient suffers from sleep apnea that requires cpap treatment: more than 15 ahi per hour in a sleep study or due to significant background diseases. * patient less than 20 years old.
improving access to psychiatric care for patients in primary care

Conditions: Mental Disorder

Summary: getting a consultation with a psychiatrist within an appropriate time is one of the main issues reported by general practitioners (gp) for patients suffering from mental disorders in primary care. consultation liaison in psychiatry is a system focused on general medicine-psychiatry collaboration. the aim of the present study is to evaluate the impact of the consultation-liaison on the adequacy of the access time to a psychiatric consultation according to the degree of urgency evaluated by the gp.

faced with the saturation of the psychiatric care system, who recognizes the key role of the gp in mental health. three-quarters of prescriptions for antidepressants and anxiolytics are performed by gps, but less than one in four people with depression have been diagnosed and treated appropriately. the gps describe difficulties in accessing psychiatric professionals and in particular to obtain a quick consultation with a psychiatrist. in different countries, psychiatric consultation-liaison (cl), centered on the collaboration of general medicine and psychiatry, have emerged. two meta-analyzes and a cochrane review were conducted on cl but no clinical trials were conducted in france. cl seems to improve patients' health at 3 months as well as their satisfaction and adherence to care. results regarding the improvement of prescriptions from gp are encouraging. better clinical trials are being requested and a need for medico-economic studies is also identified. in france, a psychiatry cl was born in toulouse in 2017, the "dspp". the present study plans a 2 groups randomized clinical trial, one group of gps having access to dspp, the other not. for a period of 3 months, the gps propose to any patient, for whom they want a psychiatric consultation, to participate in the study and address him/her to a psychiatrist. the dspp is an evaluation center without long-term patient follow-up. only patient referred by his/her gp can get into the dspp.

Eligibility criteria:
inclusion criteria: * 15 years patient or older: * presenting mental suffering or a frequent or severe mental disorder * having consulted his gp who ask for psychiatric consultation * having given its consent for the use of its medico-administrative data * affiliated with the general health insurance scheme * of which the gp is from haute garonne and is voluntary to participate in the study * free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) and by one of the parents for minor participants exclusion criteria: * patient with ongoing psychiatric follow-up * patient unable to answer questionnaires (unable to read or write) * patients receiving a measure of legal protection

Keywords: accessibility of health services access to psychiatric care consultation-liaison general practitioner and psychiatrist collaboration care pathway
mr based prediction of molecular pathology in glioma using artificial intelligence

Conditions: Glioma

Summary: this registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, mgmt methylation, idh and tertp mutations, etc) and conventional/advanced/new mr sequences (t1, t1c, t2, flair, adc, dti, pwi, etc) of patients with primary gliomas. by leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict molecular pathology or subgroups of gliomas.

non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, mgmt methylation, idh and tertp mutations is challenging. with the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced mr imaging (t1 weighted imaging, t2 weighted imaging, flair, contrast-enhanced t1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of molecular pathology of gliomas. the creation of a registry for primary glioma with detailed molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Eligibility criteria:
inclusion criteria: * patients must have radiologically and histologically confirmed diagnosis of primary glioma * life expectancy of greater than 3 months * must receive tumor resection * signed informed consent exclusion criteria: * no gliomas * no sufficient amount of tumor tissues for detection of molecular pathology * patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices * patients who are pregnant or breast feeding * patients who are suffered from severe systematic malfunctions

Keywords: molecular radiomics deep learning machine learning
nordic icd (cardioverter defibrillator implantation) trial

Conditions: Ventricular Tachyarrhythmia

Summary: the purpose of the nordic icd study is to evaluate whether icd implantation without intra-operative df testing is non-inferior to icd implantation with intra-operative df testing regarding the efficacy of the first icd shock for the treatment of true spontaneous ventricular tachyarrhythmias.

the nordic icd study is justified by the need to compare the clinical outcome between patients that did receive defibrillation (df) testing and those who did not receive df testing during icd implantation. the nordic icd study will evaluate the impact of intra-operative df testing on the long-term icd first shock efficacy for true ventricular tachyarrhythmias in the observational period. therefore, the primary analysis of this study will consider all ventricular tachyarrhythmia episodes treated by icd shock(s) during the trial follow-up period. moreover, the home monitoringtm system of biotronik will be used in order to monitor the technical system integrity, device programming and cardiac performance continuously. it supports early information about the occurrence of vt/vf (ventricular tachycardia/ventricular fibrillation) episodes and corresponding therapies such as icd shocks. the home monitoringtm capability offered by active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of cardiac performance. 1077 patients were enrolled and randomized (1:1) in 48 centers in five european countries (germany, czech republic, denmark, sweden and latvia).

Eligibility criteria:
inclusion criteria: * indication for implantation of a single chamber icd, dual chamber icd and crt-d therapy according to the acc/aha/esc 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death and the 2010 focused update of esc guidelines on device therapy in heart failure (class i recommendations) * primary or secondary prophylaxis * first icd implantation with no pre/existing or previous icd therapy or icd system * the patient is willing and able to comply with the clinical investigation plan * patient has signed informed consent exclusion criteria: * age ≤ 18 years * arvc or hypertrophic cardiomyopathy * vf due to acute ischemia or other potentially reversible causes * actively listed for a transplant * unable or unwilling to participate in the study * unavailable for required follow-ups and study procedures * participating in another clinical study other than a registry or observational/non-interventional study * anticipated right sided implantation of icd generator * malignant condition with a life expectancy less than the duration of the study * pregnant and breast-feeding women * terminal renal insufficiency * persistent af without pre-operative tee (transesophageal echocardiography) * persistent af with left atrial thrombus diagnosed by tee

Keywords: icd df test intra-operative df testing vt
neurocognitive effects of bilateral stn versus gpi dbs in parkinson's disease patients with mci

Conditions: Parkinson's Disease; Mild Cognitive Impairment; Dementia

Summary: purpose: this is a prospective single-center, randomized, patient and evaluator-blind clinical trial to compare the neurocognitive outcomes of globus pallidus interna (gpi) versus subthalamic nucleus (stn) deep brain stimulation (dbs) in parkinson's disease (pd) patients with mild cognitive impairment (mci).

deep brain stimulation (dbs) of the globus pallidus interna (gpi) or subthalamic nucleus (stn) has been accepted as the surgical treatment of choice for patients with advanced parkinson's disease (pd), demonstrating improvements in motor function that exceed those achieved by medical management alone. unfortunately, a paucity of data exist comparing non-motor outcomes between dbs of the available targets. specifically, a high prevalence of concurrent cognitive dysfunction or early dementia exists in pd patients, and it is unclear whether dbs target selection may have differential effects with regards to cognitive outcomes in pd patients with early evidence of mild cognitive impairment previous studies indicate that stimulation of either the gpi or stn is associated with decrements in patients' verbal fluency, visuospatial memory, as well as overall cognitive decline, but those patients were randomized without consideration for baseline neurocognitive performance and it is unclear whether these effects are due to treatment or rather the natural history of these patients. in addition to the clinical arm of this trial, another secondary goal is to evaluate several biomarkers obtained from blood and cerebrospinal in order to determine their utility if any as prognosticators of patient cognitive and motor outcomes. specifically, we will be evaluating levels of amyloid 1-42, total tau, phosphorylated tau 181, and brain derived neurotrophic factor in the cerebrospinal fluid as well as genotyping the apolipoprotein-e gene. these proteins and genotypes are still currently under investigation as potential biomarkers for dementia as well as neuroplasticity.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease * deemed an appropriate candidate for dbs surgery * montreal cognitive assessment (moca) score \< 25 * neuropsychological testing with the diagnosis of mild cognitive impairment exclusion criteria: * no diagnosis of parkinson's disease * not appropriate for dbs surgery

Keywords: parkinson's disease dementia
a novel sperm selection method provides advantages over conventional approaches

Conditions: Male Infertility

Summary: the goal of this clinical trial is to know if a novel sperm selection device (ca0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. the main questions it aims to answer are: does the ca0 sperm selection device increases the sperm concentration? does the ca0 sperm selection device increases the sperm motility? what are the differences in sperm membrane potential when ca0 is used? do intracellular calcium levels change when ca0 is used? does ca0 increase fertilization rates? researchers will compare ca0 to the standard of care for sperm selection (density gradient centrifugation) to see if ca0 has similar performance participants will: provide a semen sample have their semen sample analyzed, processed and used for assisted reproduction technologies


Eligibility criteria:
inclusion criteria: * normozoospermic (18-35 years old) and teratozoospermic (18-60 years old) patients undergoing ivf/icsi cyles with at least 2 days of sexual abstinence exclusion criteria: * less than 4 oocytes collected during oocyte retrieval * total sperm count less than 30x10\^6

Keywords: spem preparation in vitro fertilization sperm membrane potential sperm intracellular calcium
a phase 3, multi-center, randomized, double-blind, placebo-controlled, study of fostamatinib disodium in the treatment of waiha

Conditions: Warm Antibody Autoimmune Hemolytic Anemia

Summary: the primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (waiha).


Eligibility criteria:
inclusion criteria: 1. subject must have a diagnosis of primary or secondary warm antibody autoimmune hemolytic anemia (waiha) as documented by a positive direct antiglobulin test (dat) specific for anti-igg or anti-iga. 2. have failed or not tolerated at least one prior waiha treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mmf, danazol, vincristine, esa or splenectomy (folate, iron or other supplements do not fulfill this criterion). 3. have haptoglobin \ uln or lactate dehydrogenase (ldh) \>uln. 4. at screening, subject's hemoglobin level must be ≤9 g/dl or if hemoglobin value \>9 g/dl and \<10 g/dl, subject must be on an allowed waiha treatment and the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain). 5. karnofsky performance status (kps) ≥70. 6. subject's concurrent treatment for waiha may consist of no more than two of any of the following agents: azathioprine, steroids, esas, mycophenolate mofetil, dapsone or danazol at a stable dose exclusion criteria: 1. subject with other types of antibody autoimmune hemolytic anemia (aiha) (e.g., cold antibody aiha, cold agglutinin syndrome, mixed type aiha, or paroxysmal cold hemoglobinuria). 2. subject has aiha secondary to autoimmune disease, including systemic lupus erythematosus (sle), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement. 3. subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥135 mmhg or diastolic blood pressure ≥85 mmhg, whether or not the subject is receiving anti-hypertensive treatment. 4. subject has one or more of the following laboratory abnormalities at screening: neutrophil count of \ 1.5 x uln. 5. has documented active hepatitis b or hepatitis c infection or hiv infection.

Keywords: waiha warm antibody autoimmune hemolytic anemia warm autoimmune hemolytic anemia
fluvastatin, rosuvastatin added to pegylated interferon and ribavirin

Conditions: Chronic Hepatitis C

Summary: hypothesis: addition of fluvastatin will increase the cure rate of standard anti-hcv therapy. summary: this trial is limited to veterans in oklahoma who qualify for care with the veterans administration. it is a randomized control format including genotypes 1 and 3. there will also be pilot arms for hcv carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. in all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per fda package insert.


Eligibility criteria:
inclusion criteria: * not previously treated. * off alcohol and marijuana for 6 months * hcv rna positive exclusion criteria: * hiv positive * advanced liver disease * advanced cardiopulmonary disease * chronic renal failure

Keywords: fluvastatin hepatitis c chronic hepatitis c not previously treated with pegylated interferon and ribavirin
red light photobiomodulation and topical disinfectants

Conditions: Healthcare Associated Infection; Nosocomial Infection; Surgical Site Infection

Summary: the goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. the fourth week of consist of only red light treatment. culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.

this is an exploratory, single-center, open-label, single-arm study with microbiological endpoint using photobiomodulation (pbm) and topical disinfectants to determine the effect on the nasal microbiota. the photobiomodulation system distributes about 700mw of light to each nostril using a 2-channel diode laser with non-thermal, red light. the topical disinfectants are methylene blue (0.01%) and chlorhexidine gluconate (0.25%). following a pretreatment nasal culture, these two disinfectants will be administered into the patient's anterior nares followed by a two-minute light cycle. this process is repeated once more resulting in two treatments cycles (4-minutes total). following this, nasal cultures are taken immediately and at 4-, 8-, 24-, and 48- hours. broad spectrum and staphylococcus spp. culturing of nasal swabs will be conducted. swabs will also be submitted for next generation sequencing to characterize the effect of light and disinfectants on the nasal microbiome.

Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older exclusion criteria: * pregnant women * those under 18 years of age * prisoners * mentally disabled persons

Keywords: staphylococcal aureus methylene blue chlorhexidine gluconate nasal decolonization photobiomodulation photodynamic therapy nasal microbiome